Clinical Trials Join the Remote Work Revolution: FDA’s New Draft Guidance on Decentralized Clinical Trials
FDA Law Blog
MAY 4, 2023
Study visits can be conducted using telehealth visits if in-person interaction is not necessary. The draft guidance also states that informed consent can be collected remotely or electronically as part of a DCT, so long as there is institutional review board oversight. Trial personnel can also be sent to participant’s homes.
Let's personalize your content